510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152464Substantially Equivalent

ORAcollect.Dx

DNA Genotek Inc., Ottawa, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152464 is the FDA 510(k) clearance record for ORAcollect.Dx, a class II device, cleared for DNA Genotek, Inc. on under FDA product code OYJ (Dna Specimen Collection, Saliva). FDA's definition for product code OYJ reads: "A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing". FDA records list 8 510(k) clearances for DNA Genotek, Inc., from to . As of , FDA records show one recall naming K152464.

Clearance record

Decision date
Received
(269 days to decision)
Product code
OYJ Dna Specimen Collection, Saliva
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
DNA Genotek, Inc. 2 Beaverbrook Rd., Ottawa, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYJ

Trailing 12 months

FDA records hold no clearances under product code OYJ in the trailing twelve months.

FDA records show no clearances under product code OYJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OYJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260